Ex Parte Qi et al

Board of Patent Appeals and Interferences

Aug 4, 2009

10790914 (B.P.A.I. Aug. 4, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte FENGXIA QI, PAGE W. CAUFIELD,
and PING CHEN
__________

Appeal 2009-001908
Application 10/790,914
Technology Center 1600
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Decided: August 4, 2009
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Before TONI R. SCHEINER, LORA M. GREEN,
and JEFFREY N. FREDMAN, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of treating a gram-positive infection, which the Examiner has rejected on
grounds of enablement and anticipation. We have jurisdiction under 35
U.S.C. § 6(b). We reverse.
Statement of the Case
Background
“Production of mutacins by S. mutans and other oral streptococci may
also play a protective role to the host against pathogens such as Group A
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Application 10/790,914

streptococci and Streptococcus pneumoniae. In this respect, mutacins may
serve as antimicrobial agents in the future” (Spec. 2, ll. 6-9).
The Claims
Claims 9-28 are on appeal. We will focus on claim 9 which is
representative and reads as follows:
9. A method of treating or preventing a gram-positive
infection in a subject, said method comprising administering
to said subject an effective amount of a purified and isolated
peptide having the amino acid sequence as set forth in SEQ
ID No: 2, or a pharmaceutically acceptable salt, amide, ester,
or prodrug thereof.

The Prior Art
The Examiner relies upon the following prior art references
to show unpatentability:
O’Brien et al., Recognition and management of bioterrorism
infections, 67 AMERICAN FAMILY PRACTICE 1927-1934 (2003).
Koch et al., Enterococcal Infections: host response, therapeutic and
prophylactic possibilities, 22 VACCINE 822-830 (2004).
Ooshima et al., Effect of Mutacin Administration on Streptococcus
mutans-Induced Dental Caries in Rats, 29 MICROBIOL. IMMUNOL. 1163-
1173 (1985).
Ikeda et al., Purification and Certain Properties of a Bacteriocin from
Streptococcus mutans, 35 INFECTION AND IMMUNITY 861-868 (1982).

The Issues
The rejections as presented by the Examiner are as follows:
A. The Examiner rejected claims 9-28 under 35 U.S.C. § 112, first
paragraph as failing to comply with the enablement requirement (Ans. 3-7).
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B. The Examiner rejected claims 9-10 under 35 U.S.C. § 102(b) as
anticipated by Ikeda (Ans. 7-8).
C. The Examiner rejected claims 9-10 under 35 U.S.C. § 102(b) as
anticipated by Ooshima (Ans. 7-8).
A. 35 U.S.C. § 112, first paragraph Enablement
The Examiner finds that the “specification has not shown that mutacin
I can be used to treat or prevent infections caused by all gram-positive
microorganisms. The claimed invention broadly encompasses any infection
or disease caused by any gram-positive microorganism” (Ans. 5).
Appellants contend that “the enablement rejection under review lacks
the required information showing that one of skill in the art would not know
how to make and use the claimed invention with reference to any particular
gram-positive organism” (App. Br. 11).
In view of these conflicting positions, we frame the enablement issue
before us as follows:
Have Appellants demonstrated that the Examiner erred in finding that
it would have required undue experimentation to treat or prevent gram-
positive infections in a subject using the peptide of SEQ ID NO: 2?

Findings of Fact (FF)
Breadth of Claims
1. Claim 9 is drawn to the treatment of “gram-positive infection”
without limitation as to type of infection or type of organism (see claim 9).
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2. The Examiner finds that “[t]he claimed invention encompasses
a method of treating or preventing all gram-positive bacterial infections”
(Ans. 4).
Amount of Direction or Guidance Presented
3. The Specification teaches that “[m]utacin I has the following
advantages over conventional antimicrobial agents: 1) it has a wide spectrum
of antimicrobial activity against a wide range of gram-positive bacteria
including the multidrug-resistant Staphylococci and Enterococci, the major
culprits of IVC-related infections” (Spec. 18, ll. 1-5).
4. The Specification teaches that because mutacin I “is produced
by a normal member of the human oral biota, it is unlikely to elicit immune
response from the patient or has any toxicity to the host” (Spec. 18, ll. 10-
12).
5. The Specification teaches that “[m]utacins are active against
closely related species as well as a surprisingly wide spectrum of other
Gram-positive bacteria. Parrot et al. (1990) Can. J. Microbiol 36:123-130)”
(Spec. 1, l. 24 to 2, l. 3).
Working Examples
6. The Examiner finds that “there are no working examples in the
instant specification that demonstrate effectiveness of the peptide against all
gram-positive microbial infections” (Ans. 6).
State of the Art and Unpredictability of the Art
7. The Examiner finds that “O'Brien et al has taught that gram-
negative bacteria can be quite difficult to diagnosis as well as manage
infections caused by these organisms” (Ans. 5).
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8. The Examiner makes no finding that it would have been
unpredictable to determine whether mutacin would function to treat disease.
Caulfield Declaration
9. The Caulfield Declaration teaches that “[m]utacin I proved
highly effective against streptococci, effective against vancomycin-resistant
Enterococcus, and of varying efficacy against multiple resistant Staph
aureus depending on the concentration and purity of the preparation”
(Caulfield Declaration ¶ 6).
10. The Caulfield Declaration teaches that “semi-purified mutacin
I, II, and III were found effective on an overlayer of Bacillus anthracis
Sterne” (Caulfield Declaration ¶ 6).
Principles of Law
“In order to satisfy the enablement requirement of section 112, an
applicant must describe the manner of making and using the invention ‘in
such full, clear, concise, and exact terms as to enable any person skilled in
the art … to make and use the same ….’ 35 U.S.C. § 112, para. 1.”
Rasmusson v. SmithKline Beecham Corp., 413 F.3d 1318, 1322 (Fed. Cir.
2005).
Factors to be considered in determining whether a
disclosure would require undue experimentation …
include (1) the quantity of experimentation necessary, (2)
the amount of direction or guidance presented, (3) the
presence or absence of working examples, (4) the nature
of the invention, (5) the state of the prior art, (6) the
relative skill of those in the art, (7) the predictability or
unpredictability of the art, and (8) the breadth of the
claims.

In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988).
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The Examiner has the initial burden to establish a reasonable basis to
question the enablement provided for the claimed invention. See In re
Wright, 999 F.2d 1557, 1561-62 (Fed. Cir. 1993) (Examiner must provide a
reasonable explanation as to why the scope of protection provided by a
claim is not adequately enabled by the disclosure).
Analysis
The Specification teaches, and the Caulfield Declaration
demonstrates, that Mutacin I is an effective antibiotic with activity against a
variety of gram positive microorganisms (FF 3-5, 9-10).
The Examiner, while arguing that the full scope of the claim is not
enabled, cites no art, evidence or specific scientific reasoning to suggest
unpredictability in determining whether mutacin I will have antibiotic
activity against any particular gram positive microorganism (FF 1, 2, 7, 8).
Balancing the Wands factors, we agree with Appellants that undue
experimentation would not have been required to make and use the claimed
invention. There is no evidence to suggest that mutacin I would fail to
function as an antibiotic and there is no reasonable reason to doubt that
mutacin I would be effective against a variety of gram positive organisms
(FF 9-10). The Examiner has not satisfied the initial burden to establish a
basis to question the enablement of the claimed invention.
The Examiner's position that the Specification cannot teach how to
use the claimed method unless it teaches solutions to all possible species and
all possible gram positive organisms is contrary to controlling case law. See,
e.g., In re Brana, 51 F.3d 1560, 1568 (Fed. Cir. 1995). A claim may
encompass inoperative embodiments and still meet the enablement
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requirement of 35 U.S.C. § 112, first paragraph. See Atlas Powder Co. v. E.I.
Du Pont De Nemours & Co., 750 F.2d 1569, 1576 (Fed. Cir. 1984), In re
Angstadt, 537 F.2d 498, 502-3, (CCPA 1976), In re Cook, 439 F.2d 730, 732
(CCPA 1971).
Conclusion of Law
Appellants have demonstrated that the Examiner erred in finding that
it would have required undue experimentation to treat or prevent gram-
positive infections in a subject using the peptide of SEQ ID NO: 2.
We reverse the rejection of claims 9-28 under 35 U.S.C. § 112, first
paragraph, enablement.
B. 35 U.S.C. § 102(b) over Ikeda
The Examiner finds that “Ikeda et al teach that when water or diet
containing the bacteriocin from Streptococcus mutans was administered to
animals the caries score of these animals was found to be significantly
reduced” (Ans. 7). The Examiner finds that the “amino acid sequence as set
forth in SEQ ID NO: 2 would be inherent in the teachings of the prior art”
(Ans. 8).
Appellants contend that “the protein bacteriocin C3603 is not
equivalent to the protein of SEQ ID No: 2 described in the present
specification and included in claims 9 and 10. For example, the molecular
weight of bacteriocin C3603 is cited as 4800 Daltons (Ikeda et al., Abstract)
which contrasts with the smaller size of the protein of SEQ 1D No: 2
described in the present specification” (App. Br. 8).
In view of these conflicting positions, we frame the anticipation issue
before us as follows:
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Have Appellants demonstrated that the Examiner erred in finding that
the Ikeda teaches a bacteriocin which inherently comprises SEQ ID NO: 2?
Findings of Fact
11. Ikeda teaches that “[b]acteriocin C3603 . . . was subjected to . .
. electrophoresis . . . and a single band was detected by protein stain . . . The
molecular weight value of 4,800 . . . was obtained by sedimentation
equilibrium analysis” (Ikeda 863, col. 1).
12. Ikeda teaches that “[p]reliminary composition studies indicate
that bacteriocin C3603 contains aspartic acid, threonine, serine, glutamic
acid, glycine, alanine, valine, methionine, isoleucine, tyrosine,
phenylalanine, tryptophan, lysine, and arginine” (Ikeda 866, col. 1).
13. The Specification teaches that for mutacin I, the “estimated
molecular weight was 2364 Da” (Spec. 7, l. 13).
14. SEQ ID NO: 2 of the Specification is reproduced below:

Principles of Law
“[A]nticipation of a claim under § 102 can be found only if the prior
art reference discloses every element of the claim ….” In re King, 801 F.2d
1324, 1326 (Fed. Cir. 1986) (citing Lindemann Maschinenfabrik GMBH v.
American Hoist & Derrick Co., 730 F.2d 1452, 1458 (Fed. Cir. 1984)).
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“[A]bsence from the reference of any claimed element negates anticipation.”
Kloster Speedsteel AB v. Crucible, Inc., 793 F.2d 1565, 1571 (Fed. Cir.
1986).
“If the prior art reference does not expressly set forth a particular
element of the claim, that reference still may anticipate if that element is
‘inherent’ in its disclosure.” In re Robertson, 169 F.3d 743, 745 (Fed. Cir.
1999). “Inherency, however, may not be established by probabilities or
possibilities. The mere fact that a certain thing may result from a given set of
circumstances is not sufficient.” Id. (quoting Continental Can Co. v.
Monsanto Co., 948 F.2d 1264, 1268 (Fed. Cir. 1991)) (internal quotation
marks and citations omitted).
Analysis
Comparison of the amino acid composition of SEQ ID NO: 2 with the
amino acid composition of bacteriocin C3603 of Ikeda shows that SEQ ID
NO: 2 contains the amino acids leucine, cystine, asparagine, and proline
while bacteriocin C3603 does not contain these amino acids.
At a minimum, if the bacteriocin C3603 comprised SEQ ID NO: 2, it
would need to comprise all of the amino acids found in SEQ ID NO: 2. As
it does not, the Examiner has not established that bacteriocin C3603 may
comprise SEQ ID NO: 2.
The Examiner misunderstood this point of Appellants, as shown by
the Examiner’s statement that “the additional amino acids comprised in the
bacteriocin of the prior art does not mean that the protein as set forth in SEQ
ID NO: 2 is not inherently present” (Ans. 16). It is not that the prior art has
additional amino acids, but rather that the prior art bacteriocin C3603 lacks
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amino acids found in SEQ ID NO: 2 and cannot therefore comprise SEQ
ID NO: 2.
Consequently, since bacteriocin 3603 cannot comprise SEQ ID NO: 2
because it does not contain leucine, cysteine, asparagine or proline, all
amino acids found in SEQ ID NO: 2, Ikeda does not anticipate claims 9 and
10 either expressly or inherently.
Conclusion of Law
Appellants have demonstrated that the Examiner erred in finding that
Ikeda teaches a bacteriocin which inherently comprises SEQ ID NO: 2.
We reverse the rejection of claims 9-10 under 35 U.S.C. § 102(b) over
Ikeda.
C. 35 U.S.C. § 102(b) over Ooshima
The Examiner finds that “Ooshima et al teach that when water or diet
containing the bacteriocin from Streptococcus mutans was administered to
animals the dental caries of these animals was found to be significantly
reduced (see the Abstract). The amino acid sequence as set forth in SEQ ID
NO: 2 would be inherent in the teachings of the prior art” (Ans. 8).
Appellants contend that “the two articles, Ikeda et al. and Ooshima et
al., refer to the same protein ‘bacteriocin C3603’” (App. Br. 9). Appellants
contend that “the protein bacteriocin C3603 is not equivalent to the protein
of SEQ ID No: 2 described in the present specification and included in
claims 9 and 10” (App. Br. 9).
We agree with Appellants that Ooshima teaches that “[b]acteriocin
C3603 was isolated from the culture supernatant of S. mutans C3603
(serotype c) as described previously (7)” (Ooshima 1164). We further agree
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that the citation for the method of isolation is to the Ikeda reference
discussed above (see Ooshima 1172).
Consequently, since bacteriocin 3603 cannot comprise SEQ ID NO: 2
because it does not contain leucine, cysteine, asparagine or proline, all
amino acids found in SEQ ID NO: 2, Ooshima does not anticipate claims 9
and 10 either expressly or inherently.
We reverse the rejection of claims 9-10 under 35 U.S.C. § 102(b) over
Ooshima.
CONCLUSION
In summary, we reverse the rejection of claims 9-28 under 35 U.S.C.
§ 112, first paragraph, enablement.
We reverse the rejection of claims 9-10 under 35 U.S.C. § 102(b) over
Ikeda.
We reverse the rejection of claims 9-10 under 35 U.S.C. § 102(b) over
Ooshima.
REVERSED

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